NCT02629146已完成4 期
A Single Center, Prospective, Randomized, Double Blind, Placebo-controlled, Three-way Cross-over Study of the Analgesic Effects of Midazolam Versus Placebo With Fentanyl as an Active Control in Human Volunteers
Wilhelminenspital Vienna1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2015年12月最近更新:
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Change in pain ratings (0-100) to a suprathreshold heat pain stimulus
研究概览
简要总结
This study evaluates analgesic properties of midazolam compared to placebo and fentanyl. Each participant will receive all three drugs (midazolam, fentanyl, placebo) on three different occasions (study visits) and the effect on different pain stimuli will be tested.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •male and female volunteers
- •18-40 years old
- •body mass index between 5th and 85th percentile
- •Caucasian
- •non smoker or moderate smoker (<10 cigarettes per day)
- •able to understand, write, and read German
排除标准
- •acute or chronic pain condition (except for mild day-to-day pain on <5 days/month)
- •previous (up to 5 days preceding the study) or current medications prescription or over-the-counter, especially analgesics
- •symptoms of a clinically relevant illness in the 2 weeks before the first study day
- •hypertension
- •any known psychiatric condition
- •abuse of alcoholic beverages, drug abuse
- •known positive human immunodeficiency virus status
- •any known medical condition which may interact with study medication, study objectives, or compliance of subject with study tasks
- •participation in a clinical trial in the 4 weeks preceding the study
- •known allergy against Midazolam
- •known allergy against Fentanyl
- •pregnancy or breast-feeding
- •unable or unwilling to give informed consent
- •unable or unwilling to follow investigator's instructions
- •unable or unwilling to comply with study protocol
研究组 & 干预措施
Midazolam
Experimental
Drug: Midazolam (experimental)
干预措施: Midazolam (Drug)
Isotonic saline
Placebo Comparator
Drug: Isotonic saline (placebo)
干预措施: Isotonic saline (Drug)
Fentanyl
Active Comparator
Drug: Fentanyl (active comparator)
干预措施: Fentanyl (Drug)
结局指标
主要结局
Change in pain ratings (0-100) to a suprathreshold heat pain stimulus
时间窗: 3.5 Minutes after end of infusion
次要结局
- Change in pain ratings to a suprathreshold electrical pain stimulus(3.5 Minutes after end of infusion)
- Increase of pressure pain thresholds (kPa)(Up until 23 Minutes after end of infusion)
研究者
Burkhard Gustorff
Univ.Prof. Dr.
Wilhelminenspital Vienna
研究点 (1)
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